Ch08 HCEN9297 02 2010 10 PDF

Chapter 8
Technical data and specifications -

AK 200 ULTRA S
Contents
Performance and specification - Control System . . . . . . . . . . . . . . . . . 8:2

Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:2
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . 8:5
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5
Substitution fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5
Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Diascan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . 8:12
Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Performance and specification - Supervisory system . . . . . . . . . . . . . . 8:15
Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:15
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:16
Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:16
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:16
Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . 8:16
Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:17
Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:17
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:18
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:18
Materials in contact with water, concentrates and dialysis fluid . . . . . . 8:19
Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20
Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20
Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20
China RoHS declaration table according to SJ/T 11363–2006 . . 8:23
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:25
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:1
Program version 10.xx
Performance and specification - Control
System
Note
• When accuracy ranges are written as e.g. “(±1 ml/min or
±1%)” the widest range is valid.
• For the qualified technician, the Service Manual for the
AK 200 ULTRA S dialysis machine is available. The Service
Manual provides all the necessary information for the safe and
required maintenance of the machine.
Note
Blood Flow Control

Values for the blood pump(s) are based on the arterial blood pump with
a pump segment of 7.9 mm and 2.0 mm wall thickness. For paediatric
blood tubes with pump segment of 4.0 mm it is also possible to set
blood flow to 10 or 15 ml/min. Accuracy is then ±5 ml/min.
Double Needle
Blood Flows in HD, single 20 to 500 ml/min (±10 ml/min or ±15%)

pump
Blood Flows in HDF, HF 20 to 700 ml/min (±10 ml/min or ±15%)
Accumulated blood volume 0 to 327 litres (±0.6 l * treatment time (h)
or ±15%)
Single Needle Single Pump (HD, HDF only)
Arterial flow 20 to 500 ml/min (±10 ml/min or ±18%)

Time control 2 to 20 sec (±1 sec), Arterial and venous
time. The actual clamp opening time is
depending on blood flow rate, size of
expansion chamber and pressure limits.
Pressure control 10 to 600 mmHg (±50 mmHg), venous
pressure control
Accumulated blood volume 0 to 327 litres (±0.6 l * treatment time (h)
or ±18%)
Single Needle Double Pump (HD only)
Double pump-A 20 to 800 ml/min

Double pump-V 20 to 800 ml/min
Mean Flow-SN/DP 10 to 400 ml/min (±10 ml or ±15%)
Accumulated blood volume 0 to 99.9 litres (±0.6 l * treatment time
(h) or ±15%)
Stroke Volume-SN/DP 20 to 60 ml/stroke (±15%) at a cycle time
< 20 s
8:2 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Air Detection
Sensitivity Bubbles larger than 1 μl will be trapped

by the drip chamber. An alarm will be
issued if the blood level falls below the
middle of the air detector.
Venous drip chamber size 22 mm
(diameter)
Heparin Administration
Heparinization 0/0.5 to 10 ml/h (±1 ml or 0.2 ml *

heparinization time (h) or ±5%)
Stop time, can be preset 0 to 4.00 h.min (±1 min) (20 min)
(Default)
Syringe size, can be preset 10 to 30 ml (30 ml)
(Default)
Maximum counter pressure +650 mmHg
The accuracy is based on tests with 20 ml and 30 ml syringes
Blood Volume Sensor (BVS)
Relative blood volume - 40% to + 10% from reference value

∆BV (Standard deviation ±3%) Sensor active
for Hb ≥ 80 g/l and blood flow ≥180
ml/min
Blood Pressure Monitor (BPM)

The alarm limits below can be preset. The value put in brackets and in
italics is the default value.
Systolic pressure range1 60 - 250 mmHg

Low alarm limit 60 - 250 mmHg (100 mmHg)
High alarm limit 60 - 250 mmHg (150 mmHg)
Diastolic pressure range1 40 - 200 mmHg
Mean pressure range1 45 - 235 mmHg
Pulse rate range 40 - 200 bpm (±2 bpm or ±2 % of
reading)
Low alarm limit 40 - 180 bpm (40 bpm)
High alarm limit 40 - 180 bpm (150 bpm)
1 Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard deviation

8 mmHg
Dialysis fluid preparation
Temperature
Dialysis Fluid Temperature 30-39 °C (+0,5/-1,5 °C) (+0,5/-2,0 °C)

at fluid flow < 500 ml/min. Accuracy is
valid only if dialysis fluid temperature is
greater or equal to ambient temperature.
Temperature low alarm, can 28 to 40 °C (35°)
be preset (Default)
Temperature high alarm, 28 to 40 °C (39°)
can be preset (Default)
Fluid flow
Dialysis Fluid Flow Rate 300 to 700 ml/min (±10 ml/min)
Conductivity
Conductivity measuring 0.1 - 20 mS/cm (±0.1 mS/cm)

Alarm limits in Acetate ±5 % of set value
mode
Alarm limit in Bicarbonate ±5% of set value for A-step conductivity
mode, A-step
Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity
mode, B-step
Alarm limits are extended to 10% for maximum 2 minutes of 10
minutes
Concentration
Na+, Acetate mode 115 to 160 mmol/l (±4 mmol/l)

Na+, Bicarbonate mode 130 to 150 mmol/l (±6 mmol/l)
HCO3-, Bicarbonate mode 20 to 40 mmol/l (±6 mmol/l)
Concentrates
Max. pressure for +50 kPa

concentrates
pH supervision
pH measurement of 1 to 9.9 pH units (±0,2 pH units for

Dialysis Fluid pH 5 to 9, ±0,5 pH units for pH<5 or
pH>9)
pH low alarm, can be preset 1 to 15 pH units (6 Acetate mode, 6.5
(Default) Bicarb mode)
pH high alarm, can be 1 to 15 pH units (8 Acetate mode, 7.8
preset (Default) Bicarb mode)
Degassing
Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-630

Acetate mode, can be preset mmHg) Minimum 75 mmHg absolute
(Default) pressure
Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-580
Bicarbonate mode, can be mmHg) Minimum 75 mmHg absolute
preset (Default) pressure
Dialysis fluid preparation (BiCart Select mode only)
Fluid flow
SelectBag Proportioning 1:400 (±3%)

Ratio SelectBag Proportioning Ratio is defined
as the quotient SelectBag flow/dialysis
fluid flow
On-line Saline Priming (OSP)
Sodium concentration 154 mmol/l (±4 mmol/l)
Ultrafiltration control
UF volume max. 30 litres (±50 ml or ±50 ml * passed

treatment time (h) or ±2.5%)
UF-rate 0.0 to 4.0 l/h
Treatment Time 0.05 to 9.59 hour.minute (±1 minute)
Pressure control (On-line mode)
Constant TMP in on-line mode, where TMP for AK 200 ULTRA S dial-
ysis machine is defined as the difference, Pb out - Pd out, where Pb out
is the venous drip chamber pressure and Pd out is the pressure measured
in the dialysis fluid, where it enters the machine after the dialyzer.
TMP -200 to +550 mmHg (±15 mmHg)
Substitution fluid
Substitution fluid flow rate 0.3 to 27.0 litres/h (±10%) at 500 ml/min
flow rate. Limitations at lower flow rates.
Substitution volume max. 150 litres
Profiling
UF-rate 0 to 4 l/h
Na+, Acetate mode 115 to 160 mmol/l
Na+, Bicarbonate mode 130 to 150 mmol/l
HCO3-, Bicarbonate mode 20 to 40 mmol/l
Half-times:
Degressive Set in h.min, 10 to 25% of remaining

treatment time
Progressive Set in h.min, 75 to 90% of remaining
treatment time
Diascan
Accuracy is valid in HD double needle and on-line HDF postdilution,
for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min,
UF profiling is allowed.
Clearance, K 0 to 350 ml/min (±10%)

Cumulated water volume 0 to 100 l (±10%)
cleared of urea, Kt
Dialysis dose, Kt/V 0 to 3 (±10%)
Plasma sodium, Na+ 130 to 160 mmol/l
Disinfection and Cleaning
Temperature and time in different phases and concentration of
disinfectant are possible to preset. The values in this specification are
the default values and what the machine has been validated against.
Follow the instructions from the manufacturer of the disinfectant, to set
the correct dilution and dwell time. All disinfection programs in the
AK 200 ULTRA S dialysis machine are tested in accordance with the
French standard NFS 90-304 and established to fulfil the requirements
expressed in the same standard. Time for disinfection programs is
estimated and may vary.
All values below are applicable for the 230V AC variant. For the 115V
AC variant add 7 minutes to all heating programs.
Heat disinfection Program
Temperature 93 °C
Fill up phase 13 minutes
Circulation phase 15 minutes
Drain phase 4 minutes
Total time 32 minutes
Heat disinfection Program with CleanCart
Decalcification CleanCart-C
Cleaning CleanCart-A
Temperature 93 °C
Fill up and mixing phase 13 minutes
Rinse/Drain phase 15 minutes
Heat disinfection Program with liquid citric acid
Temperature 93 °C
Concentration 20 % citric acid
Concentration in machine 2 % citric acid; i.e. diluted 1 + 9
Consumption Approx. 260 ml
Heat disinfection Program with WRO 300 H
Temperature 93 °C
Low flow heat phase 20 minutes
Drain phase 4 minutes
Heat disinfection Program with CleanCart including WRO 300 H
Decalcification CleanCart-C
Cleaning CleanCart-A
Temperature 93 °C
Low flow heat phase 20 minutes
Peracetic Acid Program
Concentration of 3.5 % peracetic acid

disinfectant
Concentration in machine 0.1 % ; i.e. diluted 1 + 34
Dwell time 10 minutes
Total time 73 minutes including 10 min dwell time
Low concentration Peracetic Acid Program
Concentration of 0.35 % peracetic acid

disinfectant
Concentration in machine 0.01 % ; i.e. diluted 1 + 34
Consumption approx. 85 ml
Hypochlorite Program
Concentration of 0.5% available chlorine (approximately

disinfectant 70% of sodium hypochlorite
concentration)
Concentration in machine 0.5% ; i.e. not diluted
Dwell time 10 minutes, Maximum 20 min
Formaldehyde Program
Concentration of 4% formaldehyde
disinfectant
Concentration in machine 4% ; i.e. not diluted
Central Disinfection Program
Concentration of 0.1% peracetic acid or 0.5% available

disinfectant chlorine
Concentration in machine Not diluted
Dwell time Must be preset, maximum 20 min. for
hypochlorite
Total time 63 minutes (dwell time not included)
Other programs, total time
Rinse/Drain with CleanCart 32 min

Rinse/Drain 13 min
Drain 4 min
External Cleaning 70% ethanol or 60% Isopropanol
Water supply
Water Supply Flow Rate

Treatment 450 to 850 ml/min
Disinfection 0 to 900 ml/min
Inlet Water Pressure
to regulator 120 to 800 kPa
to machine 85 to 120 kPa
Inlet Water Temperature
Treatment +5 to +30 °C
Disinfection +5 to +90 °C
Inlet Water Quality Inlet water quality must comply with
local regulations and if no such regulation
is available follow ISO 13959. Level
for conductivity shall not exceed 0.1
mS/cm.It is possible to use water with
higher conductivity if it consists mainly
of sodium salts. This may however affect
the accuracy of the fluid composition.
Inlet tube length Maximum 5 m or the specially designed
spiral PEX tubing
Drain
Drain (length of tube) Maximum 5 m

Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor
If the optional air-gap on the machine is used the distance between the
air-gap and the drain must not be less than 0.3 m. For an electrically
adjustable stand in its lowest position this means that the drain must
not be higher than 580 mm. For a mechanically adjustable stand in its
lowest position the drain must not be higher than 550 mm.
Power supply
Mains Voltage 115; 230 V AC (±10%)

Frequency 50 to 60 Hz (±5 Hz)
Power Consumption Max. 2250 W at 230 V
Max. 1650 W at 115 V
Mains cable: 3 conductor cable, Length max. 3 m
rating 250 V 10 A, 13 -16A
Mains cable connector: Certified to IEC 60320/C19
Mains cable plug: Earthed plug, 250 V AC / 13 -16 A,
approved or Hospital grade, earthed plug,
125 V AC / 15 A, approved.
Earth Leakage Current max 500 μA
Patient Leakage Current max 100 μA
Fuses 2 x T 12 A
All leakage currents are specified without external equipment
connected to the machine.
Connection of external equipment
External equipment intended for connection to signal input, signal
output or other connectors, shall comply with relevant IEC standard
(e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical
electrical equipment). In addition, all such combinations - systems -
shall comply with the standard IEC 60601-1-1, Safety requirements
for medical electrical systems. Equipment not complying to IEC
60601 shall be kept outside the patient environment, as defined in the
standard. (The normal distance can be mentioned i.e. at least 1.5 m
from the patient or the patient support.) Any person who connects
external equipment to signal input, signal output or other connectors
has formed a system and is therefore responsible for the system to
comply with the requirements of IEC 60601-1-1. If in doubt, contact
qualified technician or your local representative. Use of other cables
may result in increased emissions or decreased immunity for the
equipment or system. Protective caps shall be attached when the
connectors are not in use.
External serial interface
External connector P 63 8 pin REDEL contact, black. RS-232

or RS-422 compatible connection. Opto
insulated fulfilling IEC 60601-1-1.
Attached cable length 2.5 m unshielded.
External equipment Serial port for connection to PC used for
logging and preset.
RS-232
Max input voltage ± 15 V DC

High level min output + 5 V DC
voltage
Low level max output - 5 V DC
voltage
Max output current ± 5 mA
RS-422
Max input voltage ± 7 V DC

Diff. input threshold ± 0.2 V DC
voltage
Diff. max. output voltage 5 V DC
Diff. min. output voltage 2 V DC
Short circuit output current 100 mA
External interface
External connector P 79 8 pin REDEL, yellow, configured as 1

make- and 2 change over- relay contacts.
Attached cable length 2.9 m unshielded.
External equipment Port for connection to central alarm
system and remote control of water
system.
Contact ratings
Max voltage 24 V AC or DC
Max current 100 mA AC or DC
External I/O Interface
External connector P 76 8 pin REDEL blue. Opto insulated

fulfilling IEC 60601-1-1. Attached cable
length 1,5 m unshielded.
External equipment Connection to Gambro UF Calibration
Unit. Service purpose only.
External interface
External connector P 64 8 pin RJ-45

External equipment Ethernet port for connection to network
intended for Exalis computer system,
download, preset and logging
Battery Back-up
Battery back-up of power 24 volt, 6.5 Ah

supply
Running time >15 minutes
Fuse T 15 A
Performance and specification -
Supervisory system
Note
• When accuracy ranges are written as e.g. “(±1 ml/min or
±1%)” the widest range is valid.
Note
Blood Pressure Supervision

The alarm limits below can be preset. The value put in brackets and in
italics is the default value.
Venous Pressure
Operating range -700 to +750 mmHg

(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit HIGH max +600 mmHg (+300 mmHg)
Alarm limit LOW min -50 mmHg (-50 mmHg)
When blood is detected the operator is
requested to centralize the alarm limits
and the low limit is by default set to +10
mmHg
Arterial Pressure

(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit HIGH max +750 mmHg (+250 mmHg)
Alarm limit LOW min. -700 mmHg (-250 mmHg)
System Pressure

(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit SN/DP HIGH +300 mmHg (+175 mmHg)
max
Alarm limit SN/DP LOW -200 mmHg (+10 mmHg)
min.
Alarm limit SP HIGH max +750 mmHg (+150 mmHg)
Alarm limit SP LOW min. -
Air Detection
Sensitivity Bubbles larger than 1 μl will be trapped

by the drip chamber. An alarm will be
issued if the blood level falls below the
middle of the air detector.
Venous drip chamber size 22 mm
(diameter)
Heparin Administration
Heparinization volume ±0.3 ml of set value (±1 ml or 0.2 ml *

alarm limit heparinization time (h) or ±5%)
The accuracy is based on tests with 20 ml and 30 ml syringes
Dialysis fluid preparation
Temperature
Temperature alarm (fixed) 40 °C (±1 °C)
Conductivity
Alarm limits in Acetate ±5% of set value

mode
Alarm Limit in Bicarbonate ±5% of set value for A-step conductivity
mode, A-step
Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity
mode, B-step
Alarm limits are temporarily extended to 10%. Maximum mean
deviation for a 5 hour treatment is 0.2 mS/cm.
Dialysis fluid preparation (BiCart Select mode only)
Dialysis Fluid Flow Rate 300 - 700 ml/min (±9 ml/min)

Dialysis Fluid Flow Rate ±5%
alarm limit
SelectBag Proportioning 1:400 ±12%, alarm given within 20
Ratio alarm limit minutes. For larger errors the alarm time
is shorter.
SelectBag Proportioning Ratio is defined
as the quotient SelectBag flow/dialysis
fluid flow
Ultrafiltration
Dialysis fluid flow 300 - 700 ml/min

operating range
UF rate measurement -4.0 to +4.0 l/h (±2 ml/min) Accuracy ±5
ml/min verified at start-up.
UF rate supervision, max ±1-10 ml/min, (±5 ml/min)
allowed difference between
control and protective
system, can be preset
(Default)
Accumulated UF volume ±0.10 - 2.0 l (±0.80 l) or ±0.10 l/h *
alarm limit, can be preset passed treatment time (h)
(Default)
Treatment Time Control 0.05 to 9.59 hour.minute (±1 minute)
TMP supervision alarm -200 to +550 mmHg (±15 mmHg) For
AK 200 ULTRA S dialysis machine,
TMP is defined as the difference, Pb out
- Pd out, where Pb out is the venous
drip chamber pressure and Pd out is the
pressure measured in the dialysis fluid,
where it enters the machine after the
dialyzer.
Max UF rate alarm limit, 0.1 to 4.0 l/h (1.0 l/h)
can be preset (Default) In TMP on-line mode with settable
substitution fluid volume only.
Blood leak detection
Sensitivity ≥0.35 ml blood/min, haematocrit 32%

±2%, at 700 ml/min dialysis fluid flow
rate
Alarm response time 7 seconds
(diffusion mode)
Physical data
Depth Approx. 610 mm

Width Approx. 570 mm
Total Height Adjustable heights 1175 - 1340 mm
Five position stand 1152 - 1382 mm
Floor Area 573 x 753 mm
Weight Blood Monitor Approx. 17 kg
Weight Fluid Monitor Approx. 40 kg
Weight Stand Approx. 24 to 31 kg
Infusion Stand Height 1300 to 2150 mm
Max. load 10 kg
Transportation One man installation
Fitting into a normal Estate car
References
Assembly Drawing: K22200
Materials in contact with water,
concentrates and dialysis fluid
Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PP (Polypropylene reinforced with talcum)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)
Metals
Stainless steel SS2343
Titanium
Platinum
Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminium oxide (Al2O3)
Ceramic, Zirconium oxide (ZrO2)
Glass
Ferrite (Barium-Strontium- Ferrit)
Environmental data
Operation
If condensation occur when moving the equipment between locations
with different temperatures and high relative humidity (e.g. outdoor
and indoor locations), the inside of the equipment shall be allowed to
dry before switching on the equipment.
Ambient Temperature range +18 to +35 °C

Relative Humidity range 15 to 85% RH
Air Pressure range (atm. 700 to 1060 hPa
pressure)
Maximum altitude ≈ 2000 m above see level
Transportation and storage

During transportation and storage the equipment has to be kept in
its original packing. If transportation or storage time is more than
15 weeks, the environmental data relating to the operation has to be
followed. The maximum ambient temperature for transportation and
storage in 96% Relative humidity is +40 °C.
Ambient Temperature range -20 to +70 °C

Relative Humidity range 10 to 96% RH
Air Pressure range (atm. 500 to 1060 hPa
pressure)
Electromagnetic environment
The AK 200 ULTRA S dialysis machine is intended for use in the
electromagnetic environment specified below. The customer or the
user of the AK 200 ULTRA S dialysis machine should assure that it
is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance

RF emissions Group 1 The AK 200 ULTRA S dialysis machine uses RF
CISPR 11 energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment
RF emissions Class B The AK 200 ULTRA S dialysis machine is suitable
CISPR 11 for use in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes
Harmonic emissions Class A (Not applicable
IEC 61000-3-2 for 115 V version)
Voltage fluctuations Complies (Not
/flicker emissions applicable for 115 V
IEC 61000-3-3 version)
Immunity test IEC 60601 Compliance level Electromagnetic enviroment-guidance
test level
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD), ±8 kV Air ±8 kV Air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that
transient/burst, lines lines of a typical commercial or hospital
IEC 61000-4-4 ±1kV for ±1kV for environment.
input/output lines input/output lines
Surge ±1kV for ±1kV for Mains power quality should be that
IEC 61000-4-5 differential mode differential mode of a typical commercial or hospital
±2kV for ±2kV for common environment
common mode mode
Voltage <5 % UT <5 % UT Mains power quality should be that
dips, short (>95 % dip in UT) (>95 % dip in UT) of a typical commercial or hospital
interruptions for 0,5 cycle for 0,5 cycle environment. If the user of the
and voltage 40 % UT 40 % UT AK 200 ULTRA S dialysis machine
variations on (60 % dip in UT) (60 % dip in UT) requires continued operation during power
power supply for 5 cycles for 5 cycles mains interruptions, it is recommended
input lines. 70 % UT 70 % UT that the AK 200 ULTRA S dialysis
IEC 61000-4-11 (30 % dip in UT) (30 % dip in UT) machine be powered from an
for 25 cycles for 25 cycles uninterruptible power supply or a
<5 % UT <5 % UT battery.
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
Note
• UT is the a.c. mains voltage prior to application of the test level.
Note
Immunity test IEC 60601 Compliance level Electromagnetic enviroment-guidance
test level
Portable and mobile RF communications
equipment should be used no closer to
any part of the AK 200 ULTRA S dialysis
machine, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3V d = 1.2 P
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m d = 1.2 P 80 MHz to 800
IEC 61000-4-3 80 MHz to 2,5
d = 2.3 P 800 MHz to 2,5 GHz
GHz
Radiated RF - 30V/m where P is the maximum output power
mobile phones rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey2, should be less than the
compliance level in each frequency
range3.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Note
2 Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the AK 200 ULTRA S dialysis machine is used exceeds the
applicable RF compliance level above, the AK 200 ULTRA S dialysis machine
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating
the AK 200 ULTRA S dialysis machine.
3 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
Recommended separation distances between portable and mobile RF communications equipment
and the AK 200 ULTRA S dialysis machine
The AK 200 ULTRA S dialysis machine is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the AK 200 ULTRA S dialysis
machine can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the AK 200 ULTRA S dialysis
machine as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of (m)
transmitter
W
150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz
⎡ 3,5 ⎤ ⎡ 3,5 ⎤ ⎡7⎤
d =⎢ ⎥ P d =⎢ ⎥ P d=⎢ ⎥ P
⎣ 3⎦ ⎣ 3⎦ ⎣ 3⎦
0,01 0.11 0.11 0.23

0,1 0.37 0.37 0.74
1 1.2 1.2 2.3

10 3.7 3.7 7.4
100 12 12 23
Rated maximum - - ⎡7⎤
d=⎢ ⎥ P
output power of ⎣ 30 ⎦
mobile phone
2W - - 0.33
GSM/3G
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note
• At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
• These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Note
China RoHS declaration table according to SJ/T 11363–2006
零件名称有毒有害物质或元素
Part Name Toxic or hazardous Substances and Elements
铅汞镉六价铬多溴联苯多溴二苯醚
Lead Mercury Cadmium Hexavalent Polybrominated Polybrominated
(Pb) (Hg) (Cd) Chromium (CR biphenyls (PBB) diphenyl ethers
(VI)) (PBDE)
电路板组件
Printed Circuit X O O O O O
Board Assemblies
电气元件以及电
缆线材
Electromechanical X O O O O O
Components
including wiring
电源组件
X O O O O O
Power Supply
电池元件
X O O O O O
Batteries
金属件
O O O O O O
Metals
塑料件
O O O O O O
Plastics
外壳
O O O O O O
Enclosures
O: 表示该有毒有害物质在该部件所有均质材料中的含量均在SJ/T11363-2006标准规定的限量要求以下.
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the
limit requirement in SJ/T11363-2006.
X: 表示该有毒有害物质至少在该部件的某一均质材料中的含量超出SJ/T11363-2006标准规定的限量要求.
X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this
part is above the limit requirement in SJ/T11363- 2006.
Standards
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B
IEC 60601-2-16 Particular requirements for safety of haemodialysis,

haemodiafiltration and haemofiltration equipment
IEC 60601-2-30 Particular requirements for the safety of automatic

cycling indirect blood pressure monitoring equipment
IEC 60601-1-2 Electromagnetic compatibility
EN 1060-1 Non-invasive sphygmomanometers Part 1: General

requirements
EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary

requirements for electromechanical blood pressure measuring systems
NFS 90-304 Medico-surgical equipment Hemodialysis equipment
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Chapter 8

Technical data and specifications -

Performance and specification - Control System . . . . . . . . . . . . . . . . . 8:2

Blood Flow Control

Blood Flows in HD, single 20 to 500 ml/min (±10 ml/min or ±15%)

Single Needle Single Pump (HD, HDF only)

Arterial flow 20 to 500 ml/min (±10 ml/min or ±18%)

Single Needle Double Pump (HD only)

Double pump-A 20 to 800 ml/min

Sensitivity Bubbles larger than 1 μl will be trapped

Heparinization 0/0.5 to 10 ml/h (±1 ml or 0.2 ml *

Blood Volume Sensor (BVS)

Relative blood volume - 40% to + 10% from reference value

Blood Pressure Monitor (BPM)

Systolic pressure range1 60 - 250 mmHg

1 Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard deviation

Dialysis Fluid Temperature 30-39 °C (+0,5/-1,5 °C) (+0,5/-2,0 °C)

Dialysis Fluid Flow Rate 300 to 700 ml/min (±10 ml/min)

Conductivity measuring 0.1 - 20 mS/cm (±0.1 mS/cm)

Na+, Acetate mode 115 to 160 mmol/l (±4 mmol/l)

Max. pressure for +50 kPa

pH measurement of 1 to 9.9 pH units (±0,2 pH units for

Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-630

Dialysis fluid preparation (BiCart Select mode only)

SelectBag Proportioning 1:400 (±3%)

On-line Saline Priming (OSP)

Sodium concentration 154 mmol/l (±4 mmol/l)

UF volume max. 30 litres (±50 ml or ±50 ml * passed

Pressure control (On-line mode)

TMP -200 to +550 mmHg (±15 mmHg)

Degressive Set in h.min, 10 to 25% of remaining

Clearance, K 0 to 350 ml/min (±10%)

Heat disinfection Program

Heat disinfection Program with CleanCart

Heat disinfection Program with liquid citric acid

Heat disinfection Program with WRO 300 H

Heat disinfection Program with CleanCart including WRO 300 H

Concentration of 3.5 % peracetic acid

Low concentration Peracetic Acid Program

Concentration of 0.35 % peracetic acid

Concentration of 0.5% available chlorine (approximately

Central Disinfection Program

Concentration of 0.1% peracetic acid or 0.5% available

Rinse/Drain with CleanCart 32 min

External Cleaning 70% ethanol or 60% Isopropanol

Water Supply Flow Rate

Drain (length of tube) Maximum 5 m

Mains Voltage 115; 230 V AC (±10%)

External connector P 63 8 pin REDEL contact, black. RS-232

Max input voltage ± 15 V DC

Max input voltage ± 7 V DC

External connector P 79 8 pin REDEL, yellow, configured as 1

External I/O Interface

External connector P 76 8 pin REDEL blue. Opto insulated

External connector P 64 8 pin RJ-45

Battery back-up of power 24 volt, 6.5 Ah

Blood Pressure Supervision

Operating range -700 to +750 mmHg

Operating range -700 to +750 mmHg

Operating range -700 to +750 mmHg

Sensitivity Bubbles larger than 1 μl will be trapped

Heparinization volume ±0.3 ml of set value (±1 ml or 0.2 ml *

Dialysis fluid preparation